01.19.22 -- Outsourcing For Duchenne: Techniques For All Biopharma

Restricted access barrier systems (RABS) or isolator technologies represent an integral component of a manufacturer’s quality control strategy. The current regulatory landscape requires drug manufacturers to employ a RABS or isolator as part of their risk mitigation approach, and companies looking to develop in-house capabilities or contract to a CDMO should understand the key elements of each to make the best, most informed decision for their product.

Primary packaging is thought of as the first line of defense against the negative effects of oxygen. This article highlights other areas to consider that can help avoid drug quality degradation.

Performing the transfer of a product or technology from a small-scale development process to full-scale commercial manufacturing can be difficult; but vetting for the right CMO partner can pose its own challenges.

To provide the best service, a CDMO's facility should be equipped with flexible manufacturing platforms that can be adjusted for multiple customers while also mitigating risk.

Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. 

In the second installment of this series, experts from Pfizer CentreOne’s global network and partner organizations consider the effects of equipment design and different tablet strategies.

A panel of experts discussed challenges and opportunities related to the development, clinical phases, and commercialization of biologics. They also offered insights on how to improve sponsor-CDMO relationships.

How do you get to IND/IMPD without sacrificing quality and future commercialization goals? Expert considerations for accelerating and optimizing your early development process.

Examine the trends influencing pharmaceutical development and manufacturing strategy and how these drivers are impacting outsourced development and manufacturing strategies.

Iwan Bertholjotti, director of commercial bioconjugate development, and Dr. Bernhard Stump, head of bioconjugate development, discuss complexity and uncertainty in the bioconjugates market.

Senior vice president for business development Federico Pollano explains how the company is leveraging its 50-year experience and dual sites in Germany and the United States to flexibly meet market demand.

While the patient-centric design of decentralized trials increases convenience and provides an uninterrupted flow of medication for the patient, it can also positively impact trial enrollment and retention for sponsors.

Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologics drug product tech transfer.